TPLC - Total Product Life Cycle

• Device: monitor, ultrasonic, fetal
• Product Code: KNG
• Regulation Number: 884.2660
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVANCED INSTRUMENTATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
HERAMED LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIANA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN BESTMAN INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN BIOCARE ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CREATIVE INDUSTRY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN TAIKANG MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZZHEN LUCKCOME TECHNOLOGY INC., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VCOMIN TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2017	3	3
2018	8	8
2019	1	1
2020	2	2
2021	1	1
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4	4
Product Quality Problem	3	3
Device Operates Differently Than Expected	3	3
Temperature Problem	2	2
Insufficient Information	1	1
Protective Measures Problem	1	1
Device Sensing Problem	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Sense	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Device Inoperable	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Anxiety	5	5
Burn(s)	2	2
Burning Sensation	2	2
Cramp(s)	1	1
Death	1	1
Hemorrhage/Bleeding	1	1
High Blood Pressure/ Hypertension	1	1
Nausea	1	1
Rash	1	1
Complaint, Ill-Defined	1	1
Burn, Thermal	1	1
Electric Shock	1	1
No Known Impact Or Consequence To Patient	1	1
Shock from Patient Lead(s)	1	1
Pregnancy	1	1
Skin Burning Sensation	1	1
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Mar-19-2018